What this Trial Is About

Breast cancer diagnosis and the related mastectomy surgery can significantly impact women's social, relational, and work lives. Post-oncological breast reconstruction aims to restore the breast's volume, shape, and projection to closely match the other breast in unilateral mastectomies or to achieve symmetry between both breasts in bilateral mastectomies. This helps patients avoid using uncomfortable and visible external prostheses. This observational study evaluates whether the traditional prosthetic reconstructive technique using expanders and implants (EXP-IMPL) is still a valid option compared to newer methods, focusing on clinical outcomes, body measurements, and patient satisfaction. The study is non-interventional and observes patients who have undergone prosthetic breast reconstruction after mastectomy, either through immediate direct-to-implant reconstruction (DTI) or a two-stage expander/prosthesis approach (EXP-IMPL). Data gathered from these procedures will be analyzed statistically to compare the effectiveness and patient satisfaction of the techniques. There are no experimental treatments or interventions assigned by the study. Participants will be women aged 18 to 70 who have had mastectomy followed by prosthetic breast reconstruction. Researchers will collect clinical and anthropometric data as well as patient satisfaction information during follow-up. The main outcome measure is technical success, observed from the first patient enrolled up to the 200th patient over an average follow-up of 2 years. This will help determine the current value of the EXP-IMPL technique in breast reconstruction.

Prosthetic Breast Reconstruction After Mastectomy